Effects of DHEA/Exercise on Bone, Muscle and Balance

April 25, 2008 updated by: National Aeronautics and Space Administration (NASA)
The purpose of this study is to examine whether muscle strength and balance will improve in women with frailty selected for dehydroepiandrosterone sulfate (DHEAS) levels below 550 ng/dl treated with DHEAS supplementation and Hatha yoga. Investigators believe the effects of both treatments will improve outcomes more than either treatment alone and may be additive; in addition, lean body mass, skeletal muscle mass, markers of bone turnover and physical performance will improve following treatment with DHEA and/or yoga.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Dehydroepiandrosterone (DHEAS) and yoga may mitigate or reverse the effects of aging and frailty on bone, muscle and balance loss. The mechanism of the effects may be direct - working through androgen or estrogen receptors in bone, muscle or brain. Or the effects may be indirect, countering effects of the stress response.

The specific aims of this study are:

  1. To determine the effects of dehydroepiandrosterone sulfate (DHEAS) supplementation and/or Hatha yoga on muscle strength, balance, body composition and physical performance measures over 6 months in women with osteopenia and some degree of frailty
  2. To determine the effect of dehydroepiandrosterone sulfate (DHEAS) supplementation and/or Hatha yoga on function (physical and cognitive), bone metabolism, and cardiovascular risk factors.

Study Type

Interventional

Enrollment (Actual)

99

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • Farmington, Connecticut, United States, 06030-5215
        • University of Connecticut Health Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

63 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Women over age 65 years
  • Bone mineral density t-score less than -1
  • At least one of the five components of the frailty phenotype (low hand grip strength, low walking speed, low physical activity, weight loss or sense of exhaustion)
  • DHEAS levels less than 550 ng/dl
  • Able to come or be brought to the University of Connecticut Health Center (UCHC) for outpatient visits
  • Mammogram within the preceding 12 months

Exclusion Criteria:

  • Disease or medication known to affect bone or muscle metabolism (i.e., Paget's disease, osteomalacia or 25OHD level less than 10 ng/dl, hyperparathyroidism: current use of corticosteroids, calcitonin, heparin, phenytoin, phenobarbital, methotrexate, bisphosphonates, calcitonin, selective estrogen receptor modulator or PTH)
  • Use of androgen or estrogen in the preceding year
  • Use of psychiatric medications including antipsychotic medications and SSRI
  • Metastatic or advanced cancer (other than skin cancer)
  • History of breast cancer
  • Active cardiac ischemia by history of angina or myocardial infarction in the preceding 6 months

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
DHEA and Yoga
Dietary supplement: DHEA
50mg daily for 6 months
Other Names:
  • Dehydroepiandrosterone
Behavioral: Yoga
2 sessions per week for 6 months
Active Comparator: 2
DHEA and exercise
Dietary supplement: DHEA
50mg daily for 6 months
Other Names:
  • Dehydroepiandrosterone
Behavioral: Aerobics
Walking/chair aerobics program 2 sessions per week for 6 months
Active Comparator: 3
Placebo and Yoga
Behavioral: Yoga
2 sessions per week for 6 months
Dietary supplement: Placebo
Placebo supplement every day for 6 months
Placebo Comparator: 4
Placebo and exercise
Behavioral: Aerobics
Walking/chair aerobics program 2 sessions per week for 6 months
Dietary supplement: Placebo
Placebo supplement every day for 6 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Muscle strength, bone turnover markers
Time Frame: baseline, 3 month and 6 months
baseline, 3 month and 6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Changes in activities of daily living, cognitive and emotional function
Time Frame: baseline and 6 months
baseline and 6 months
Laboratory tests to measure factors that may reflect or influence changes in bone metabolism
Time Frame: baseline and 6 months
baseline and 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Aeronautics and Space Administration (NASA)

Collaborators

University of Connecticut

Investigators

  • Principal Investigator: Anne Kenny, MD, University of Connecticut Center on Aging

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2004

Primary Completion (Actual)

October 1, 2006

Study Completion (Actual)

October 1, 2006

Study Registration Dates

First Submitted

April 18, 2008

First Submitted That Met QC Criteria

April 18, 2008

First Posted (Estimate)

April 22, 2008

Study Record Updates

Last Update Posted (Estimate)

April 29, 2008

Last Update Submitted That Met QC Criteria

April 25, 2008

Last Verified

April 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AG0099
  • NNG04GK63G

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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